MAUDE Adverse Event Report: TIDI PRODUCTS LLC SITTER ELITE; FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED

Model Number	8345
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: visual findings observed a site sticker, indentation, and sticky residue on the exterior housing.The battery door is missing.Mounting bracket for tracking device attached at the lower end of the unit.Evaluation of the unit found that it had power when in use with batteries and ac adapter.However, the unit had no tone sound due to a faulty u1(micro-controller).After the faulty u1 was replaced with a working u1, the unit functioned as intended.The unit passed all other functional testing when voice only and mute modes were selected.Being that the unit is almost 4 years old since it was manufactured, it is unlikely that a manufacturing non-conformity contributed to the unit having no sound, and the likely cause of the reported issue is wear-and-tear, severe shock, and other effects of repeated use and age.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.The ifu states, to reduce the risk of serious injury or death, test the alarm and sensor for proper operation prior to putting in service with a patient, and each time before leaving the patient unattended.If the alarm and/or sensor do not function properly, remove the alarm and sensor from service and replace them with a properly functioning alarm and/or sensor.Do not use the alarm, sensor or magnet if it does not activate each time weight is removed from the sensor, the chair belt sensor is unfastened, or magnet is removed from face plate.Manufacturer file reference # (b)(4).
Event or Problem Description
Customer reported complaint via phone.Alarm will not power on, troubleshooting with new batteries did not resolve error, unit appears to have no damage.Sn (b)(6).Please advise when qa evaluation is complete.Called in by (b)6).The date the issue was discovered is unknown and no incident or serious injury was reported.

• Brand Name: SITTER ELITE
• Common Device Name: FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16961392
• Report Number: 2182318-2023-00052
• Device Sequence Number: 5238272
• Product Code: PJO
• UDI-Device Identifier: 10190676002082
• UDI-Public: 10190676002082
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8345
• Device Catalogue Number: 8345
• Device Lot Number: 1930KF1182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown